LOX Product Engineer

This is an onsite contract lasting approximately 6 months.

This key engineering role will be responsible for supporting CAIRE, Inc. Liquid Oxygen medical products (stationary and portable Liquid Oxygen systems) manufacturing by creating and validating manufacturing processes, managing all associated product sustaining activities, authoring all associated manufacturing documentation, and maintaining compliance with our quality system.

Essential Functions

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Responsible for Device Master Record (DMR) deliverables - validation and qualification of new product launches, manufacturing equipment, software and processes leveraging standard qualification approaches (IQ/OQ/PQ).
• While utilizing lean manufacturing tools, design, sustain and improve manufacturing assembly lines, refining BOMs, workflow processes, PFMEAs and detailed work instructions.
• Responsible for sustaining Device History File (DHF) deliverables – V&V deliverables relating to design changes of existing products – verification test protocols and reports, V&V test plan, updates to risk management file, coordination of regulatory testing (IEC 60601-1, ISO18777).
• Create and manage design changes through Engineering Change Orders (ECO).
• Maintain compliance with medical device quality system which includes leading and/or supporting corrective action Preventative action initiatives (CAPAs), discrepant material disposition and Engineering Change Order (ECO) implementation.
• Provide technical support for failure analysis and root cause investigation of product failures.
• Identify and implement continuous improvement projects with respect to first pass yield, cycle time reduction, product reliability, capacity enhancement and cost reduction, utilizing a DMAIC and DMADV structure.
• Work with Quality group to ensure that the team follows appropriate Good Manufacturing Processes (GMP), design history file (DHF), and device history record (DHR) guidelines per FDA requirements, and support design reviews in accordance with product development procedures.
• Improve product quality, yields, and reduce cost.
• Complete cost analysis and lead cost reduction efforts.
• Analyze instrument-manufacturing line from a risk perspective (PFMEA) to incorporate and validate critical tests used in manufacturing.
• Provide production line support for day-to-day engineering issues on core equipment.
• Provide technical support analyzing and /or performing failure analysis for discrepant production components, assemblies and field returns.
• Other related duties.

Competencies

• Mechanical Skills
• Project/ Task Management
• Analytical Skills
• Problem-Solving
• Good business ethics
• Communication Proficiency
• Business Acumen
• Detail Oriented
• Collaboration
• Diversity and Inclusion
• Teamwork Orientation

Supervisory Responsibility

No

Work Environment

This job operates in a professional office environment and manufacturing/distribution environment.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. This is largely a physically active role. This would require the ability to lift, bend, or stand as necessary. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Travel

Yes, Travel up to 10% per year.

Required Education And Experience

• Minimum B.S. degree in engineering discipline, M.S. preferred.
• Successful experience leading projects, and juggle multiple business demands
• Minimum of five years’ engineering experience manufacturing cryogenic medical products, or complex electro-mechanical products.
• Experience with mechanical CAD (Solidworks, Pro E), MS Project software.
• Experience in using Minitab for statistical analysis, Gage R&R.
• Experience with programming languages such as Java, Python and SQL.
• Experience developing products from concept to volume manufacturing.
• Mechanical design and analysis expertise desired.
• DMAIC and Lean Six Sigma experience, black belt preferred.
• Prior responsibility for validation of processes, equipment and products.
• Strong quantitative process development skills including (p)FMEA, tolerance analysis, DoE, SPC, GR&R, and Cpk/Cp.
• Excellent organizational skills; Able to manage multiple fast-paced projects simultaneously.
• Ability to communicate effectively and professionally across a range of technical disciplines with a broad slate of stakeholders, including management, peers, customers, and suppliers.
• Prior experience with the Design Control processes for medical devices and clinical application of surgical instruments is a plus.
• Ability to work in a Matrix org structure with cross functional Value Streams.

Preferred Education And Experience

• Experience in an ISO 18777, ISO 13485, ISO 9001, or medical device manufacturing environment preferred
• Cryogenics (Heat transfer, Thermodynamics) knowledge is a plus.

Additional Eligibility Qualifications

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.